Quality Associate - Medical Devices

Location
Santa Clara, California
Salary
Salary + bonus + benefits
Posted
Dec 23, 2020
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Micropoint Bioscience, Inc., a global provider of Point of Care (POC) medical diagnostic systems and solutions, is seeking a highly motivated individual in support of MBI’s products.

This position reports to the QA/QC Manger and will be responsible for shared duties between the Quality and Operations systems, including but not limited to IQC/FQC testing, calibration testing, in-process testing and training. Primary function will be in calibration testing for mLab products. Additional responsibilities may be added at the discretion of the Manager and contingent upon the on-going performance of the Associate.

  • Performs IQC testing and disposition of Raw Materials
  • Maintains calibration test schedule and maintains database
  • Performs Calibration Testing for mLabs, product evaluations, In process testing, Complaint investigations, Data Analysis, and Documentations.
  • Performs routine documentation of charts/logs per GMP requirements.
  • Maintains QMS system and subsystems as needed (WI/SOP for Inspection)

Requirements

  • B.S degree in Biology or Chemistry
  • Experience in biochemistry preferred
  • Experience with the execution of quality systems like CAPA, NCMR, deviations and document control
  • Knowledge of Quality Systems regulations including 21 CFR 820 and ISO 13485
  • Excellent skills in organization, record keeping and communications
  • High level of experience and understanding of GMP/GLP system requirements
  • Excellent oral and written communication skills
  • Collaborative and proactive attitude a must
  • Able to adapt to a fast-paced work environment and must have a strong work ethic to complete assignment with high quality under tight deadlines